What changed in this filing

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Item 1A. Risk Factors

2025-11-13 compared with 2025-08-13 · 124 added, 35 removed, 135 unchanged (54% of the section changed)

Our business, financial condition and operating results are affected by a number of factors, whether currently known or unknown, including risks specific to us or the healthcare industry as well as risks that affect businesses in general.

In addition to the information set forth in this Form 10-Q, you should consider carefully the factors discussed in Part I, Item 1A, “Risk Factors” in our 2024 Form 10-K (filed with the SEC on March 5, 2025).

In addition to the information set forth in this Form 10-Q, you should consider carefully the factors discussed in Part I, Item 1A.

“Risk Factors” in our 2024 Form 10-K.

The risks and uncertainties disclosed in such Annual Report and in this Form 10-Q could materially adversely affect our business, financial condition, cash flows or results of operations and thus our stock price.

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Because of such risk factors, as well as other factors affecting our financial condition and operating results, past financial performance should not be considered to be a reliable indicator of future performance, and investors should not use historical trends to anticipate results or trends in future periods.

The Samsung Investment is subject to closing conditions, including conditions beyond our control, and no assurance can be given that closing will take place on the timeline currently anticipated, or at all, or that we will achieve our goals under the definitive agreements to be entered into with Samsung C&T and/or Samsung Electronics.

Any failure to close the Samsung Investment or achieve such goals could adversely impact our business, financial conditions, results of operations and liquidity.

On October 16, 2025, we entered into a stock purchase agreement (the “Samsung Stock Purchase Agreement”) with Samsung C&T Corporation (“Samsung C&T”), Samsung Electronics Singapore Pte.

(together with Samsung C&T, the “Samsung Investors”) and Samsung Electronics Co., Ltd.

(“Samsung Electronics”), providing for the issuance and sale by us to the Samsung Investors in a private placement of an aggregate of 1,570,308 shares of our common stock, at a purchase price of $70.05 per share, upon the terms and conditions set forth in the Samsung Stock Purchase Agreement (the “Samsung Investment”).

The Samsung Investment is subject to the satisfaction of certain closing conditions set forth in the Samsung Stock Purchase Agreement, including, but not limited to:

(i) the satisfaction of certain regulatory approvals or clearances, including with respect to the Committee on Foreign Investment in the United States (“CFIUS”);

(ii) the execution of a business collaboration agreement between us and Samsung C&T by January 31, 2026 relating to, among other things, Samsung C&T’s exclusive right to commercialize our Galleri test, and obligation not to commercialize any other multi-cancer early detection test, in Korea, the funding of such commercialization by Samsung C&T, a right of first negotiation for commercial rights to Japan and Singapore and commencement conditions with respect to negotiating and implementing a Korea-based laboratory;

(iii) the execution of a strategic and operational collaboration agreement between us and Samsung Electronics by January 31, 2026;

and (vi) certain other customary closing conditions.

The agreements to be entered into in connection with such conditions are subject to the parties negotiating and entering into definitive agreements and the conditions included within the applicable definitive documents.

The Samsung Stock Purchase Agreement requires Samsung C&T and us to negotiate the business collaboration agreement in good faith, and requires all parties to use commercially reasonable efforts to enter into the business collaboration agreement and the strategic opportunities collaboration agreement.

We may experience delays and difficulties in satisfying the conditions for closing of the Samsung Investment, and no assurance can be given that closing will take place on the timeline currently anticipated or at all.

Some of the closing conditions are outside of our control and it is possible that not all of the closing conditions for the Samsung Investment will be satisfied or that we will not receive the expected proceeds on the timeline currently anticipated or at all.

For example, the Samsung Investment is subject to, among others, certain regulatory approvals and clearances, including with respect to CFIUS.

In addition, certain closing conditions require us,

Samsung C&T, and Samsung Electronics to successfully negotiate and enter into definitive agreements.

The final terms of all such definitive agreements are not yet established and such negotiation and execution, notwithstanding the term sheet attached to the Samsung Stock Purchase Agreement, may take longer than expected or may not be possible to accomplish on terms acceptable to us, or at all.

This risk is higher with respect to terms that are not fully reflected in the term sheet, such as the commencement conditions for negotiation and implementation of a Korea-based laboratory.

In addition, even if we are successful in closing the Samsung Investment and in negotiating and executing definitive agreements, no assurance can be given that any agreement we may reach will achieve our goals or be on terms that prove to be economically or strategically beneficial to us.

For example, we may not recognize or accomplish our strategic objectives under the business collaboration agreement or strategic and operational collaboration agreement, or may ultimately find ourselves restricted by the terms that we have negotiated under such agreements.

Any such adverse developments, including any failure to close the Samsung Investment, could adversely impact our business, financial condition, results of operations and liquidity.

Our business and results of operations will suffer if we fail to perform effectively.

There are market participants in the cancer detection space both in the United States and abroad, including Exact Sciences Corporation and Guardant Health, Inc., who have each introduced MCED products into the market in 2025.

In addition, Adela, Inc., DELFI Diagnostics, Inc., Exai Bio, Inc., Freenome Inc.

and Harbinger Health and Natera, Inc.

within the United States and AnchorDx, Anpac Bio-Medical Science Co., Ltd., Burning Rock Biotech Limited, Datar Cancer Genetics, Elypta AB, Gene Solutions JSC, Insighta, Singlera Genomics, Inc.

and Seekin, Inc.

outside of the United States, among others, have stated that they are attempting to develop tests designed to detect certain types of cancer, including some that will use cell free DNA (“cfDNA”) analyses.

The precision oncology market includes companies such as Roche/Foundation Medicine, Inc., Natera, Inc., Guardant, Inc., Tempus AI, Inc., Clearnote Health, NeoGenomics Laboratories, Personalis, Inc., Twist Bioscience Corp.

and Adaptive Biotechnologies Corp., among others.

These companies have or may have greater financial, technical, and other resources, such as larger research and development staff, well-established marketing and sales forces, existing integrated systems connected to health practices’ electronic health or medical records to facilitate product ordering and results delivery, may have different strategies to obtain reimbursement for their products, may deploy more effective sales and marketing campaigns or may operate in jurisdictions where lower standards of evidence are required to bring products to market.

These companies may succeed in developing, acquiring, or licensing, on an exclusive basis or otherwise, or providers, payers, patients and other stakeholders may believe that these companies or other new market entrants may have tests or services that are more effective, have higher performance, or are less costly than our products.

In addition, established medical technology, biotechnology, or pharmaceutical companies may invest to accelerate discovery and development of tests that could make our products less successful than we anticipate.

For example, large and long-tenured healthcare, life sciences, or technology companies may initiate research and development of MCED and bring significant resources and disruption to the cancer detection space.

Our ability to perform successfully will depend largely on our ability to:

• demonstrate compelling advantages in the performance and convenience of our products, including on a cost efficient basis;

• achieve market acceptance of our products by healthcare providers and patients, including through our reputation;

• achieve adequate coverage and reimbursement by third-party payors for our products;

• differentiate our product from future tests and products of third parties;

• attract qualified scientific, data science, clinical development, product development, and commercial personnel;

• obtain, maintain, defend, and enforce patent and other proprietary protection as necessary for our products;

• obtain and maintain any necessary or desirable marketing authorizations or certifications from regulators in the United States and other jurisdictions, and notified bodies;

• integrate product ordering and results delivery into practices’ electronic health or medical records systems;

• successfully collaborate with institutions in the discovery, development, and commercialization of our products;

• successfully expand our operations and implement a successful sales and marketing strategy to support commercialization.

We may not be able to perform effectively if we are unable to accomplish one or more of these or similar objectives.

Our products or future products may not perform as expected, and the results of our clinical studies may not support the launch or use of our products or future products and may not comply with the requirements, or be replicated in later studies or in the post-market or real-world setting, required to support a commercial opportunity or for any necessary or desirable regulatory clearances, approvals, or certifications, or reimbursement or coverage.

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We believe the decision will include considerations such as NHS budget, political priorities, cost-effectiveness and implementation constraints in addition to an evaluation of the final results.

We disclosed information from the prevalent screening round from the NHS-Galleri Trial.

e plan to submit the full prevalent screening analysis from NHS-Galleri, together with data from 25,000 participants in the PATHFINDER 2 study, and a bridging study (comparing the version of Galleri used in the NHS-Galleri and PATHFINDER 2 trial and the updated version that we plan to submit to the FDA for premarket approval) as part of our premarket approval application in the first half of 2026.

We disclosed information regarding the prevalent screening round of the NHS-Galleri Trial.

We plan to submit the full prevalent screening round analysis from the NHS-Galleri Trial, together with data from the first approximately 25,000 participants in the PATHFINDER 2 study, and a bridging analysis (comparing and measuring concordance of the version of Galleri used in the NHS-Galleri Trial and PATHFINDER 2 study with the updated version of the Galleri test that we plan to submit to the FDA for premarket approval) as part of our premarket approval application in the first quarter of 2026.

Various factors are likely to cause the final results to differ from a review of the first round results only.

For example, cancer screening trials designed to show clinical utility are commonly conducted over three years with an annual

screening period, because data from the first screening round only can be influenced by the fact that screening detects many prevalent late-stage asymptomatic cancers that have not yet been diagnosed.

For example, cancer screening trials designed to show clinical utility are commonly conducted over three years with an annual screening period, because data from the first screening round only can be influenced by the fact that screening detects many prevalent late-stage asymptomatic cancers that have not yet been diagnosed.

It is possible that the final results will be unsuitable or unavailable, which could have a significant adverse impact on the success of our commercial efforts for Galleri, our ability to achieve FDA authorization at all or within our anticipated timelines, our brand and reputation, our business, and our growth prospects.

Furthermore, other studies have been or may be conducted in populations (such as our SUMMIT study which was conducted in a population of tobacco users) or under other circumstances which make their results more complicated to interpret or result in data that is more difficult to compare.

Furthermore, other studies have been or may be conducted

in populations (such as our SUMMIT study which was conducted in a population of tobacco users) or under other circumstances which make their results more complicated to interpret or result in data that is more difficult to compare.

In addition, as Galleri and our research-use-only offering are currently available to customers and others, any analyses or studies, including those conducted by third parties, that use our current or future products, or that examine elements of our methylation platform, may produce results that are inconsistent to evaluate independently or comparatively from our own studies.

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These refinements may inadvertently result in unanticipated issues that may reduce our performance characteristics, such as sensitivity or specificity rates, or otherwise adversely affect the performance of our tests and their results.

Galleri was launched in the United States as an LDT in mid-2021 and an updated version was launched in December 2024.

The FDA has granted breakthrough device designation for Galleri.

We plan to complete a PMA submission for a further updated version of our Galleri test.

We may also be required or decide voluntarily to seek clearance or approval from the FDA for future products.

Galleri was launched in the United States as an LDT in mid-2021 and an updated commercial version of the Galleri test was launched in December 2024.

We plan to complete a PMA submission for a further updated version of our Galleri test, for which we expect we have substantially completed development.

We may also be required or decide voluntarily to seek clearance or approval from the FDA for future products or alternative versions of our Galleri test.

In 2024, the FDA finalized a regulation pursuant to which LDTs would be subject to the FDA’s medical device requirements through a phase-out of its historical policy of enforcement discretion over LDTs over a period of four years (the “LDT Final Rule”).

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It remains uncertain what impact this ruling may have on the FDA’s authority to review marketing applications for LDTs or to take enforcement action against LDTs.

If FDA imposed new or different requirements for marketing applications of LDTs to be reviewable in light of the District Court’s decision, LDT manufacturers seeking FDA review may be required to establish that the test is a medical device subject to the FD&C Act, which could involve significant modification to test configurations, processes, or operations.

If the FDA imposes new or different requirements for marketing applications of LDTs to be reviewable in light of the District Court’s decision, LDT manufacturers seeking FDA review may be required to establish that the test is a medical device subject to the FD&C Act, which could involve significant modification to test configurations, processes, or operations.

If we could not ultimately obtain marketing authorization for our Galleri test or other tests where required or appropriate, our business would be substantially harmed.

PMAs for tests that may be considered to fall within the court’s definition of laboratory developed tests, including those tests that are in the process of pursuing PMA approval, or if any changes or additional activities may need to be performed by GRAIL to support FDA review and PMA approval as a result of this ruling.

Moreover, FDA, other regulators, and notified bodies may require that we generate additional clinical data to support any clearance, approval, or certification we may seek, which could result in delays, increased costs, or other limitations or negative impacts on our ability to receive such clearance, approval, or certification, if at all, including narrowed indication or labeling than expected or desired.

It is possible that the District Court’s decision may limit the FDA’s authority to review or approve tests that are in the process of pursuing marketing authorization, or that we may need to perform additional activities to support FDA review of our products as a result of this ruling.

Moreover, the FDA, other regulators, and notified bodies may require that we generate additional clinical data to support any clearance, approval, or certification we may seek, which could result in delays, increased costs, or other limitations or negative impacts on our ability to receive such clearance, approval, or certification, if at all, including narrowed indication or labeling than expected or desired.

For additional information, see “-Risks Relating to Regulation and Legal Compliance-The regulatory clearance, approval, or certification processes of the FDA and comparable foreign regulatory authorities are lengthy, time-consuming, and unpredictable.

If we are ultimately unable to obtain any necessary or desirable regulatory approvals, clearances, or certifications, or if such approvals, clearances, or certifications are significantly delayed, our business will be substantially harmed.” in our 2024 Form 10-K.

Further, we plan to improve our products to enhance performance, offerings, scalability, and/or cost of goods.

Further, we plan to improve our products to enhance performance, offerings, scalability, and/or cost of sales.

However, we may not be successful in transitioning our products to a new or enhanced version or iteration.

Product development involves a lengthy and complex process and we may be unable to commercialize, validate, or improve performance of any of our products on a timely basis, or at all.

For example, to the extent an enhanced version of an existing product is developed, we may be required to conduct a non-inferiority study involving such

enhanced version as compared to the relevant then-current version of the test using data (for example, clinical data and/or real world evidence data obtained through Galleri’s commercial use as an LDT), or could be required to undertake other regulatory requirements if the enhanced version is not considered similar enough to the then- current version to conduct a non-inferiority study.

With respect to Galleri, we intend to conduct one or more bridging studies to measure and evaluate concordance, performance and safety of the subsequent, updated version of Galleri (for which we are submitting our PMA) using previously collected clinical study data and other samples.

For example, to the extent an enhanced, modified or updated version of an existing product is developed, we may be required to conduct a non-inferiority study or bridging analysis involving such version as compared to the relevant then-current version of the test using data (for example, clinical data and/or real world evidence data obtained through Galleri’s commercial use as an LDT), or could be required to undertake other regulatory requirements if the enhanced, modified or updated version is not considered similar enough to the then- current version to conduct a non-inferiority study.

With respect to Galleri, we intend to conduct one or more bridging studies to measure and evaluate concordance,

performance and safety of the subsequent, updated version of Galleri (for which we plan to submit our PMA) as compared to the version of Galleri used in our registrational trials.

We plan to conduct any such bridging studies using previously collected clinical study data and other samples.

Any such bridging study will need to be agreed upon with regulatory authorities and may be unsuccessful or insufficient to support approval.

If unsuccessful or insufficient, we would be required to revert to the existing version of the test and forego, or be delayed in, implementing any perceived or potential updates, including enhancements.

Reverting to the existing version of the test may cause delays in our PMA submission timeline.

If unsuccessful or insufficient, we would be required to revert to a prior version of the test and forgo, or be delayed in, implementing any perceived or potential updates, including enhancements, or further enhance, modify or update to a new version of the test and run additional bridging studies.

Reverting to a prior version of the test or running additional bridging studies may cause delays in our PMA submission timeline.

Additionally, planned improvements to our products may cause unintentional technical, logistical or other issues.

For example, in late 2024, we began use of a new version of Galleri, for which we are submitting our PMA, in commercial channels which incorporates significant automation and is intended to enable us to scale more efficiently with future demand.

In late 2024, we began use of an updated commercial version of Galleri in commercial channels.

This version incorporates an industrial scale platform with significant automation and is intended to enable us to scale more efficiently with future demand.

In connection with implementation of this new version of Galleri, we have experienced and may continue to experience increased turnaround times, re-processing costs and sample failures.

We continually monitor and evaluate laboratory operations and performance in an effort to achieve our intended sample processing metrics and costs;

however from time to time, processing issues may arise that could impact our operations.

We also expect that we have substantially completed development of the Galleri test version on a similar industrial scale platform that we will submit for PMA review.

If we are unable to adequately prevent these issues from occurring, or to adequately identify and remedy these issues, we may experience reputational harm, lose customers and revenue, need to offer discounts, require additional expenditures, delay our PMA application, or suffer other negative consequences.

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In May 2024, the NHS determined, based on data from an early analysis of Galleri test performance results in the intervention arm from the prevalent screening round of the NHS-Galleri Trial, not to initiate an implementation pilot in England prior to the final trial results.

We disclosed information from the prevalent screening round.

We submitted to NHS England and plan to submit to the FDA information from the prevalent screening round.

Various factors are likely to cause the final results to differ from the prevalent screening round results.

Further, it is possible that the early preliminary, interim or final data may not be as we expect, may be inconsistent with prior NHS-Galleri data, or with other studies we have conducted, or may be unsuitable to the NHS or FDA, any of which could have a significant adverse impact on the success of our commercial efforts for Galleri, our ability to achieve FDA authorization at all or within our anticipated timelines, our ability to achieve CMS or private payor reimbursement or coverage, our brand and reputation, our business, and our growth prospects.

impact the value of the particular program, and our ability to receive regulatory clearance or approval or commercialize a particular product and our company in general.

Further, it is possible that the early preliminary, interim or final data may not be as we expect, may be inconsistent with prior NHS-Galleri Trial data, or with other studies we have conducted, or may be unsuitable to the NHS or the FDA.

Similarly, in October 2025, performance and safety results from the first approximately 25,000 participants of the PATHFINDER 2 study were presented at the European Society of Medical Oncology (“ESMO”) Congress 2025.

PATHFINDER 2 was initiated in 2021 to evaluate the safety and performance of the Galleri test when added to standard of care single cancer screening in 35,878 adults aged 50

years and older with no clinical suspicion of cancer.

As a result, not all data from our PATHFINDER 2 study has been reported, and as we continue to follow up the remaining approximately 10,000 participants in the study, we may find results that are not what we expect or that may be inconsistent with data previously presented.

While we are not intending to include data from these 10,000 patients in our planned PMA submission, these data will be an important part of our future submission to, and communications with, the FDA to support our PMA.

Any unexpected, unsuitable, or inconsistent results could have a significant adverse impact on the success of our commercial efforts for Galleri, our ability to achieve FDA authorization at all or within our anticipated timelines, our ability to achieve CMS or private payor reimbursement or coverage, our brand and reputation, our business, and our growth prospects.

Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, and our ability to receive regulatory clearance or approval or commercialize a particular product and our company in general.

In addition, the information we choose to publicly disclose regarding a particular study or clinical study is based on what is typically extensive information, and you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding our business.

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companies’ ability to enter into joint ventures with non-U.S.

• compliance with tax, employment, immigration, and labor laws for employees living or traveling abroad, or for employee non-U.S.

• compliance with tax, employment, immigration, and labor laws for employees living or traveling abroad, or for non-U.S.

employees in the United States;

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trade relations with other countries.

It is unclear at this point how, if at all, such actions or other potential actions, including under the new U.S.

It is unclear at this point how, if at all, such actions or other potential actions, including under the most recent U.S.

Presidential administration, may impact our business or operations, and the uncertainty surrounding these matters might create difficulties in our efforts to partner with certain healthcare providers, suppliers, and insurance carriers.

For example, the United States has signaled its intention to change U.S.

trade policy, including renegotiating or terminating existing trade agreements and leveraging tariffs.

In April 2025, the United States imposed additional tariffs on imports from China and announced reciprocal and sectorial tariffs on imports from other countries.

In July 2025, the United States announced that certain tariff rates, which were initially set to expire on July 9, 2025, will now expire on August 1, 2025 and new reciprocal tariff rates will take effect on August 1, 2025.

Should these tariffs be implemented and sustained for an extended period of time, they could increase our expenses, reduce our margins or increase our prices, make it difficult to obtain inputs we need for our products or have a material adverse effect on the broader economy.

For example, the United States has maintained elevated tariffs and targeted trade measures on imports from China and has signaled continued use of reciprocal and sector-specific actions that could expand or shift over time.

Enforcement focused on Chinese supply chains—such as tighter anti-transshipment scrutiny and product-specific actions—has increased compliance complexity and could disrupt sourcing, raise input costs, and constrain pricing or margins.

Similar policies may be applied or adjusted with respect to other countries, and ongoing policy changes or legal challenges could lead to further volatility in rates, coverage, and enforcement.

Such actions could increase our expenses, reduce our margins or increase our prices, make it difficult to obtain inputs we need for our products or have a material adverse effect on the broader economy.

These risks and impacts may be exacerbated by additional tariffs in the United States or retaliatory tariffs imposed by other governments.

Our success depends in part on our ability to attract and retain the best available personnel with the necessary qualifications, which in a competitive global market means that our recruitment efforts should not be limited entirely to the United States.

To the extent U.S.

immigration-related policies, laws, rules, proclamations or orders restrict our ability to attract, or increase the cost of attracting, international talent, this could adversely impact our business and results of operations.

For example, the current U.S.

administration's decision, announced September 19, 2025, that, subject to limited exceptions, petitions for H-1B visas should be approved only if they are accompanied by a payment of $100,000, could hamper our recruitment efforts for any new personnel who require such a visa.

Additional changes in U.S.

immigration policies, rules, laws or orders could further increase our recruitment costs or delay key projects that require specialized expertise.

In addition, restrictions or delays in the issuance of other visas or in immigration processing could adversely affect our ability to collaborate effectively with our employees outside the United States and to retain the qualified personnel needed for our operations.

Moreover, future operational expansion into other geographies will subject us to additional political and regulatory regimes that will require us to invest further in compliance efforts and may result in additional risks, including, among others, exposure to various and potentially conflicting regulations, international sanctions and compliance rules, country-specific requirements for testing, approval, and processing of patient information and biological samples, as well as the risks associated with political and macroeconomic climates in any such geographies.

For example, the potential commercialization of Galleri with the NHS, subject to the results of the NHS-Galleri Trial, may be delayed or otherwise impacted if there is a change in the government in the United Kingdom.

These and other risks associated with our planned international operations may materially and adversely affect our business, costs and growth prospects.

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For additional information, see “—Risks Relating to Regulation and Legal Compliance.”

Changes in funding, leadership, resources or prioritization, or other disruptions, in the U.S.

or international government, including at the FDA, other government agencies, and notified bodies, could hinder our ability to develop, approve, certify, commercialize or receive reimbursement for our test.

Our ability to develop, approve, certify, commercialize or receive reimbursement for our test depends on interactions with, decisions of and approvals and payments by the U.S.

and other governments.

The ability of the FDA, foreign regulatory agencies, and notified bodies to review and clear, approve, or certify new products or changes to existing products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes, the FDA’s, foreign regulatory agencies’, and notified bodies’ ability to hire and retain key personnel and accept the payment of user fees, government shutdowns, and other events that may otherwise affect the FDA’s, foreign regulatory agencies’ and notified bodies’ ability to perform routine functions.

For example, in January 2025, federal employees were offered the option to make a deferred resignation and in April 2025 approximately 3,500 FDA staff positions were eliminated.

These reductions in staff, and any future reductions, impact the workforce and resources of the FDA available to review products such as ours.

Average review times at the FDA, foreign regulatory agencies, and notified bodies have fluctuated in recent years as a result of these factors.

Disruptions at the FDA, other agencies, and notified bodies may also slow the time necessary for new medical devices or modifications to cleared, approved, or certified medical devices to be reviewed and/or approved, or certified by necessary government agencies or notified bodies, which would adversely affect our business.

For example, in recent years, the U.S.

government has shut down several times, including an extended shutdown beginning on October 1, 2025.

These shutdowns could have a broad range of negative effects on our business.

For example, certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities.

We also receive certain government reimbursement payments for tests provided to patients in our REACH clinical trial, and these payments may be delayed or not provided if the government remains shutdown, or they are not budgeted for as part of any continuing resolution.

In the future, this risk could be amplified as we continue to seek, and hope to achieve, additional government reimbursement for our test.

Additionally, the government shutdown may occupy the attention of legislators or provide a difficult political environment for other legislative agenda topics, which could prevent or delay passage of legislation we support, such as the proposed legislation to enable coverage of FDA-approved MCED tests by Medicare.

If a prolonged government shutdown occurs, or occurs again in the future, we could suffer any of these negative effects, or others, any of which could have a material adverse effect on our business.

In addition, global health crises have impacted the ability of the FDA, foreign regulatory agencies, and notified bodies to perform their regular activities.

For example, during the COVID-19 pandemic, the FDA postponed most inspections of domestic and foreign manufacturing facilities at various points and the FDA has had to manage submission review times.

Significant impact on the ability of the FDA, other regulatory authorities, or notified bodies to timely review and process our regulatory submissions, could have a material adverse effect on our business.

In the EU, for example, notified bodies must be officially designated to certify products and services in accordance with the EU IVDR.

Their designation process, which is significantly stricter under the new Regulation, has experienced considerable delays due to the COVID-19 pandemic.

Despite a recent increase in designations, the current number of notified bodies designated under the new Regulation remains significantly lower than the number of notified bodies designated under the previous regime.

The current designated notified bodies are therefore facing a backlog of requests as a consequence of which review times have lengthened.

This has been one of the reasons for the recent extension of the transitional provisions under the EU IVDR.

Despite these recent developments, the way we are conducting or intend to conduct our business in the EU and the EEA and the ability of the applicable notified body to timely review and process our regulatory submissions and perform its audits may still be impacted, and our ability to commercially launch Galleri in the EU and EEA could be delayed.

We have launched Galleri as an LDT in the United States.

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If we are required to provide additional analyses or additional data or perform additional clinical studies beyond those we currently contemplate to support the intended uses of our products or future products, our planned commercial launches may be delayed and we may be required to cease commercialization of any products we currently market as LDTs.

A delay in the launch of our products or new versions of existing products,

or significantly narrowing their intended uses, could negatively impact our financial condition and results of operations.

A delay in the launch of our products or new versions of existing products, or significantly narrowing their intended uses, could negatively impact our financial condition and results of operations.

In addition, Congress has, for over the past decade, considered a number of proposals, which if enacted, would subject LDTs to additional regulatory requirements.

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If the FDA does not have authority to regulate LDTs as medical devices, there could be significant impacts to us and our industry, and our ability to compete could be impaired.

We have invested significantly in pursuing a PMA for Galleri, including conducting our NHS-Galleri and PATHFINDER 2 studies to support our PMA.

We have invested significantly in pursuing a PMA for Galleri, including conducting our NHS-Galleri Trial and PATHFINDER 2 study to support our PMA.

We believe PMA approval for Galleri, if obtained, could bolster our position in the MCED market, and increase or accelerate provider and patient adoption, commercial and government reimbursement and coverage, and international opportunities.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1A. Risk Factors